AAMI News September 2017

Congress Requires FDA to Address Device Service

The FDA Reauthorization Act of 2017 is poised to impact the healthcare technology community in two significant ways: through the renewal of the “user fees” imposed on medical device manufacturers and with a call for a report that will dive into the hot issue of medical device service, especially by third parties.

This legislation, which was signed into law by President Donald Trump on Aug. 18, will allow the Food and Drug Administration (FDA) to collect more than $320 million in user fees from medical device manufacturers over the next five years to fund the agency’s regulatory activities.

It also includes a provision requiring the FDA to produce a report that addresses “the continued quality, safety, and effectiveness of devices … with respect to servicing” within 270 days of being signed into law. The bill defines servicing as “refurbishing, reconditioning, rebuilding, remarketing, repairing, remanufacturing, or other servicing of the device.”

According to section 710 of the act, the report must include:

Findings from the FDA’s March 2016 call for comments regarding the “refurbishing, reconditioning, rebuilding, remarketing, remanufacturing, and servicing of medical devices performed by third-party entities and original equipment manufacturers,” which generated 176 original submissions.

Information presented during the October 2016 public workshop of the same title.

A description of the statutory and regulatory authority of the FDA with respect to the servicing of devices conducted by any entity.

Details of how the FDA regulates servicing and how it could improve such regulation using existing or additional authority.

Information on actions the FDA could take under its current authority to assess servicing, including the size, scope, location, and composition of third-party entities.

Information on actions the FDA could take to track adverse events caused by servicing errors.

Information regarding the regulation by states, The Joint Commission, or other regulatory bodies of device servicing.

Any additional information determined to be relevant.

The Medical Imaging & Technology Alliance (MITA) applauded the president for signing the Medical Device User Fee Amendments (MDUFA), one aspect of the overall reauthorization act.

“We commend the president and the bipartisan efforts of Congress to enact MDUFA IV, which will improve the transparency and efficiency of the FDA review process for the benefit of patients,” said Joe Robinson, chairman of the MITA board of directors and senior vice president of health systems solutions at Philips Healthcare. “The passing of this legislation is the result of a concerted effort by MITA and its industry partners who worked closely with the FDA and Congress. We are confident that this legislation will be a critical component in ensuring that all patients have timely access to life-saving medical technologies.”

In an earlier statement, MITA acknowledged section 710, writing: “Currently, only medical device service activities performed by a manufacturer are regulated by the FDA. If a device fails to perform in a safe and effective manner due to improper servicing by an unregulated, third-party organization, it could potentially put the patient at risk for serious physical injury or result in low image quality—which could lead to a delayed or missed diagnosis.”

In May, MITA testified before the House Energy and Commerce Committee’s health subcommittee about the need to expand FDA oversight to third-party servicers.

For many healthcare technology management (HTM) professionals, though, section 710 is a solution in search of a problem.

“The discussions last year with the FDA have already provided plenty of proof that there are very few issues that need their attention,” said Binseng Wang, director of quality and regulatory affairs at WRP32 Management, Inc. and Greenwood Marketing LLC. “Everybody can save a lot of money, energy, and resources not to pursue something that does not really exist out there. This is like a wild goose chase.”

Wang, whose statements represent his personal views and not those of his employer or any other organization, called on the HTM field to “either do something now or forever hold your peace!”

Still, others are less concerned by the legislation and have advocated for more of a “wait and see” approach.

“Other than calling for this report and setting a corresponding deadline, which the FDA may or may not meet, the FDA Reauthorization Act of 2017 may not result in anything new when it comes to the long-running service debate, but we will have to wait and see,” William Hyman, a consultant in New York, wrote in a post on the AAMIBlog.

During the congressional hearing back in May, Jeffery Shuren, director of the FDA’s Center for Devices and Radiological Health seemed reluctant to provide a clear position on the thorny question of regulatory oversight of medical device service and instead deferred to the judgment of Congress.

“We are not at the stage where the agency or the administration has made a determination one way or the other on whether—or what—action should be taken, but if Congress has a perspective on what we should be doing, that would be very helpful,” he said.